{"answer":{"query":"Jynarque","resolved_as":"applications","packages":7,"applications":["NDA204441"],"identity":{"application_numbers":["NDA204441"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true},{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2018-04-23","latest":"2020-01-13","packages_with_a_start_date":7}},"generic_entry":[{"application":"NDA204441","date":"2030-04-07","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"10905694","productNo":"001"},"latest_patent_expiry":"2030-04-07","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":10,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":0,"fact_id":"47eac1164f7e11352bb8072b"}],"label_history":{"events_total":9,"non_cmc_events":8,"counts_by_class":{"LABELING":2,"REMS":6},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA204441","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-15","documents":[{"type":"Letter","date":"2026-09-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204441Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204441s016lbl.pdf","untrusted":true}}],"fact_id":"eb7ac6acc7241d316ffd67e2"},{"application":"NDA204441","submission_no":14,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2025-04-23","documents":[{"type":"Letter","date":"2025-05-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204441Orig1s014ltr.pdf","untrusted":true}}],"fact_id":"89b5a71d6c1388cc4062abae"},{"application":"NDA204441","submission_no":10,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2023-09-29","documents":[{"type":"Letter","date":"2023-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204441Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"837f69ed5df71e23507cf515"},{"application":"NDA204441","submission_no":9,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2020-11-25","documents":[{"type":"Letter","date":"2020-11-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204441Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"d8a18e784e3d8588612e3565"},{"application":"NDA204441","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-10-19","documents":[{"type":"Letter","date":"2020-10-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204441Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-12-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204441s008lbl.pdf","untrusted":true}}],"fact_id":"3629077da81810529348cdb9"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"AB2":5},"marketing_status_counts":{"Prescription":5},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA204441","product_no":"002","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"JYNARQUE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"30MG","untrusted":true}},{"application":"NDA204441","product_no":"003","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"JYNARQUE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"45MG","untrusted":true}},{"application":"NDA204441","product_no":"001","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"JYNARQUE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"15MG","untrusted":true}},{"application":"NDA204441","product_no":"004","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"JYNARQUE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"60MG","untrusted":true}},{"application":"NDA204441","product_no":"005","te_code":"AB2","marketing_status":"Prescription","drug_name":{"text":"JYNARQUE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"90MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Tolvaptan","untrusted":true},"brand":{"text":"Jynarque","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":37490637.26,"claims":2472,"beneficiaries":281,"average_spending_per_claim_usd":15166.115396,"fact_id":"a46ca11042229aa38f3f1e3f"},{"year":2021,"gross_spending_usd":46234049.88,"claims":2848,"beneficiaries":341,"average_spending_per_claim_usd":16233.865829,"fact_id":"e68751e0d3cf466c4229f17a"},{"year":2022,"gross_spending_usd":60705731.07,"claims":3535,"beneficiaries":390,"average_spending_per_claim_usd":17172.766922,"fact_id":"35582ff77dcb3e517c3566e7"},{"year":2023,"gross_spending_usd":76164443.59,"claims":4158,"beneficiaries":486,"average_spending_per_claim_usd":18317.567001,"fact_id":"5261774b83f8fb704a675f36"},{"year":2024,"gross_spending_usd":103477556.21,"claims":5415,"beneficiaries":585,"average_spending_per_claim_usd":19109.428663,"fact_id":"b895371efac319b0243d05bb"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}